Yet another Pradaxa death lawsuit has been filed in Minnesota as more and more plaintiffs come forward with allegations that the defendant, Boehringer Ingelheim, Inc., fraudulently concealed the fact that their popular blood thinner lacks a bleeding antidote and thus poses a significantly higher risk of death through hemorrhage.
Hilts v. Boehringer Ingelheim Pharmaceuticals, Inc. et al (case # 0:14-CV-00839) was filed by Janet Hilts, wife and trustee of the heirs of James Hilt, who died of a fatal gastrointestinal hemorrhage on Jan. 5, 2012. The decedent had been prescribed Pradaxa in September of 2011.
The plaintiff contends that if her husband or his doctors had known of the bleeding risks associated with taking Pradaxa, they would have chosen an alternative blood thinner to treat his medical condition. She is suing for wrongful death, medical and hospital expenses, loss of income, loss of consortium, legal fees, and punitive damages, alleging that the defendant produced a defective and unreasonably dangerous drug with inadequate warning labels, that their representation of the drug’s benefits and risks were fraudulent, and for breach of implied warranty and punitive damages.
Pradaxa bleeding side effects
Pradaxa (the brand name of dabigatran etexilate mesylate) was introduced with FDA approval into the U.S. market in October of 2010. It is an anticoagulant (blood thinner) intended to treat patients with non-valve related atrial fibrillation (iregular heartbeat) and to lower the risk of blood clots and strokes. It was intended as a competitor for the often-prescribed Coumedin (warfarin), which required regular blood testing and monitoring; Pradaxa, on the other hand, was marketed as a more convenient drug that required no such testing,. Like all blood thinners, Pradaxa posed some risk of bleeding or hemorrhage; however, in a significant drawback, the drug lacks an antidote for such bleeding (Coumedin can often be treated with Vitamin K).
Several studies in 2012 pointed to a significantly elevated number of bleeding incidents and deaths (including gastrointestinal and intracranial hemorrhage) as well as a elevated heart attack risks. Boehringer Ingelheim contests the accuracy of the studies; however, the FDA has called for further study on the relative safety of Pradaxa vs. Coumedin in terms of bleeding and heart attack risks.
Pradaxa death lawsuit the latest among thousands
Over 2,000 lawsuits have been filed against the drug’s manufacturer, Boehringer Ingelheim, Inc. Most of the lawsuits have been consolidated as part of a multidistrict litigation (or MDL) under Judge David Herndon in East St. Louis, IL. (In an MDL, lawsuits with similar complaints are consolidated in one location for the purpose of pre-trial discovery, but will be tried separately, with individual outcomes).
Bellwether cases for the MDL, initial trials which should give participants some sense of how juries will respond to the evidence in future cases, are scheduled for September of 2014 and March of 2015.
Lawsuits against the company are also taking place in other courts. The Hilt case is being filed in Minnesota because a good part of the German-based manufacturer’s marketing, advertising, and distributing of the drug took place in this state. The plaintiff and decedent are from New York State.
Resources
Resources
- Forbes, Excess Risk of Cardiac Events Associated with Dabigatran http://www.forbes.com/sites/larryhusten/2012/01/09/excess-risk-of-cardiac-events-associated-with-dabigatran
- NY Times, A Promising Drug With a Flaw http://www.nytimes.com/2012/11/03/business/a-rising-anti-stroke-drug-is-tied-to-risk-of-bleeding-deaths.html
- Bloomberg, Boehringer to Pay $931,000 Fine Over Lost Pradaxa Files http://www.bloomberg.com/news/2013-12-10/boehringer-to-pay-931-000-fine-over-lost-pradaxa-files.html